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In two days, two of Europe’s top inspectional readiness professionals will lead attendees through all aspects of the inspections process. Whether it's a pre-approval, scheduled or for cause inspection, these techniques will ensure attendees will be prepared.

Thomas Peither and Bernhard Gotter — two of the industry’s most respected inspection readiness professionals — will conduct a one-of –a –kind workshop that walks attendees through the inspection process.

Attendees will learn exactly what motivates an FDA or national authority investigator and what they look for when conducting an inspection.

Their techniques include interactive role-playing exercises and roundtable discussions. This will ensure attendees are fully prepared for their next inspection — whether it’s a pre-approval, scheduled or for-cause inspection.

Specifically attendees will learn:

What the basis for an inspection is

oThe similarities and differences between the various national authorities
oThe top 10 issues cited in FDA and PIC/s observations and why they occur
oThe diversity of regulatory inspections in Europe

How to prepare for an inspection

oHow to manage the language hurdle
oHow to set up a world class back office — one that improves efficiency and productivity
oWays to demonstrate GMP compliance throughout the company
oHow to research an investigator and interpret past work and signs
oHow to set up the perfect inspection team for a company

How to behave during an inspection

oHow to use role playing to prepare for an investigator’s arrival
oHow to react when an investigator identifies an observation
oWhat’s important to object to and what organizations should accept

What happens after the inspection

oHow to respond to inspection observations including — FDA 483s and warning letters
oHow to create and properly maintain a remediation plan
oHow to communicate the findings to the organization

Who Will Benefit:

QA/QC managers and directors

Compliance personnel

Regulatory affairs professionals

Production managers

Production supervisors

Quality inspection and test managers

Process development staff

Training managers

Purchasing Agents involved in outsourcing production or processes

Recall coordinators

General/corporate counsel

Meet the Instructors:
Thomas Peither — Thomas Peither is the founder and CEO of Peither & Consultants GmbH. Thomas has over 20 years of GMP consulting experience working with some of the world’s largest pharmaceutical and biotech companies. He is a sought-after expert in all facets of cGMP. Plus, he’s recognized as a sought-after speaker who provides expert insights into current developments within the field of GMP. Peither & Consultants prides itself on focusing on customer satisfaction by identifying the needs of its customers using a proven programmatic approach. Thomas is also a co-director of Maas & Peither AG — also known as GMP Publishing. Given his international experience, he has been invited to be involved with numerous high-level initiatives within various national and international professional organizations.

Bernhard Gotter — Bernhard Gotter, Ph.D. studied pharmaceutical science at the Martin-Luther-University in Halle, Germany. After his studies, he did a Ph.D. in a biopharmaceutical research group. In 2011 Bernhard entered the pharmaceutical industry at the Bayer site in Grenzach. There, he started as a QA associate with responsibilities in audit and inspection management, supplier management, change control and qualification and validation activities.

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